FDA Adverse Event Malfunction Summary report: N

COULTER LH 500 HEMATOLOGY ANALYZER

MDR report key: 3942668 · Received July 17, 2014

Report

Report Number: 1061932-2014-01680
Event Type: Malfunction
Date Received: July 17, 2014
Date of Event: June 20, 2014
Report Date: June 20, 2014
Manufacturer: BECKMAN COULTER
Product Code: GKZ
PMA / PMN Number: K042724
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THE GROUND WIRE CONNECTED TO THE MANUAL ASPIRATION BAR WAS RESTRICTING THE PROBE WIPE BLOCK TRAVEL CAUSING THE RINSE BLOCK TO LEAK FLUID. THE FSE REROUTED THE GROUND WIRE AND RESOLVED THE FLUID LEAK ISSUE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE GROUND WIRE ON THE ASPIRATION BAR WHICH RESTRICTED MOVEMENT OF THE PROBE WIPE. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED APPROXIMATELY TEN (10) MILLILITERS OF FLUID LEAKED FROM THE PROBE WIPE BLOCK WHILE ANALYZING PATIENT SAMPLES IN PRIMARY MODE INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE FACILITY HAS AN EXPOSURE CONTROL PLAN IN PLACE FOR BIOHAZARD MATERIAL. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
418756	COULTER LH 500 HEMATOLOGY ANALYZER	COUNTER, DIFFERENTIAL CELL	GKZ	BECKMAN COULTER	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1